● Collecting relevant documents and preparing documents to be presented in supervisory visits and inspections.
● Analyzing, and interpreting approvals, regulations, and guidelines of the regulatory organization.
● Communicating with regulatory agencies regarding potential regulatory inspections, regulatory requirements, or clarification and follow-up of submissions under review.
● Familiarity with GMP requirements.
● Familiarity with pharmacopeia standards.
● Proficient in regulatory matters and ability to write CTD.
● Sufficient familiarity with quality control laboratory processes.
● Proficient in following up on all technical, scientific, and pharmaceutical affairs of the company.
● Ability to communicate with the Food and Drug Administration.
● Proficient in English.
● Problem-solving skills.
● Attention to detail.
● Analytical thinking.
● Mastering the principles and techniques of negotiation.
● Ability to communicate effectively.
● At least three years of relevant work experience.
● Bachelor's or Master's degree in Chemistry.